A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

Condition(s) studied

Investigational drug(s) / intervention(s)

Darolutamide (BAY 1841788): Darolutamide administered per local standard of care in combination with ADT.

ADT: Androgen deprivation therapy administered per local standard of care.

Docetaxel: Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.

Study summary

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (\<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

Eligibility

Primary outcome measure(s)

• Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year — after 1 year of treatment
  To describe the effectiveness of darolutamide + ADT + docetaxel in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.
• Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year — after 1 year of treatment
  To describe the effectiveness of darolutamide + ADT in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA\<0.2 ng/mL) after 1 year of study treatment.

Trial sites (16)

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